The Association of G9a Protein and Clinical Outcome of Patients With Vulvar Cancer

March 27, 2023 updated by: Sheng-Mou Hsiao, Far Eastern Memorial Hospital

Far Eastern Memorial Hospital

To assess the G9a expression in vulvar cancer

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Vulvar cancer can be treated with surgery, radiotherapy or chemoradiotherapy. Recurrence of vulvar cancer generally can be detected by imaging study. Currently, there is a paucity of sensitive marker to detect the recurrence of vulvar cancer. G9a is a recently identified protein with histone lysine methyltransferase activity. The role of histone methyltransferases in promoting tumorigenesis and progression of human cancers has been noted in some cancers, such as ovarian cancer, endometrial cancer and cervical cancer. The role of G9a protein in vulvar cancer remains obscure.

All female patients with vulvar cancer or vulvar intraepithelial neoplasm II /III who underwent surgery at Far Eastern Memorial Hospital from January 2003 will be included. All patients' clinical characteristerics including age, stage, pathologic finding, and follow-up data will be recorded from chart review.

The archived specimens will be used for immunohistochemical staining of G9a protein. Tumor size, local invasion, lymph node metastasis, and final disease stage will be determined. Correlation will be performed between G9a and clinical outcome of vulvar cancer.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • New Taipei
      • Banqiao, New Taipei, Taiwan, 22050
        • Recruiting
        • Far Eastern Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All patients' clinical characteristerics including age, stage, pathologic finding, and follow-up data were recorded from charts.

Description

Inclusion Criteria:

  • All female patients with vulvar cancer or vulvar intraepithelial neoplasm II /III who underwent surgery at Far Eastern Memorial Hospital from January 2003 were included.

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between clinical outcome of vulvar cancer and G9a
Time Frame: 5 years
The association of G9a protein and clinical outcome (such as overall survival and progression-free survival) of patients with vulvar cancer
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between histopathologic features of vulvar cancer and G9a
Time Frame: 1 year
Correlation between histopathologic features (such as tumor grade, lymphovascular space invasion, lymph node metastasis and tumor size) of vulvar cancer and G9a
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between histopathologic features of vulvar intraepithelial neoplasm and G9a
Time Frame: 1 year
Correlation between histopathologic features of vulvar intraepithelial neoplasm and G9a
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Far Eastern Memorial Hospital

Collaborators

Gynecologic Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2018

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

October 1, 2018

First Submitted That Met QC Criteria

October 2, 2018

First Posted (Actual)

October 4, 2018

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 107008-F

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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